Olanzapine/samidorphan

Drug Profile

Olanzapine/samidorphan

Alternative Names: ALKS 33/olanzapine; ALKS 3831; Olanzapine/ALKS 33; Samidorphan/olanzapine

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Alkermes plc
  • Class Amides; Antipsychotics; Benzodiazepines; Oxazepines; Small molecules; Thiazepines
  • Mechanism of Action Dopamine D1 receptor antagonists; Dopamine D2 receptor antagonists; Opioid mu receptor antagonists; Serotonin 2 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Schizophrenia
  • Phase II Alcoholism

Most Recent Events

  • 03 Oct 2016 Alkermes initiates enrolment in a phase I metabolic trial for Schizophrenia
  • 01 Sep 2016 Alkermes initiates a phase I pharmacodynamics trial in Healthy volunteers in USA (PO, Tablet) (NCT02922426)
  • 01 Aug 2016 Alkermes completes a phase I pharmacokinetics trial for Schizophrenia in USA (PO) (NCT02804568)
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